a monoclonal antibody, nimotuzumab, as treatment for recurrent or metastatic cervical cancer

Conditions: Uterine Cervical Cancer

Summary: the following is an open label, non comparative, pilot study of palliative treatment as a second, third line or more of treatment in patients with recurrent, persistent or metastatic cervical cancer; it has a limited sample of 15 patients with the primary goal of evaluating the response (defined as: complete, partial or stable disease) to treatment with a monoclonal antibody, nimotuzumab, on a weekly basis + cddp 50mg/m2/bsa as a single agent every 3 weeks for patients with good renal function (creatinine clearance =\> 60) or gemcitabine 800 mg/m2/bsa in patients with renal failure (creatinine clearance \<60). secondary objectives consist of evaluating disease-free survival, overall survival and assess patient tolerance to treatment with nimotuzumab.


Eligibility criteria:
diagnostic criteria: * female patients in whom a diagnosis of cervical cancer of epithelial origin has been confirmed by histologic and/or radiologic assessment. * said patients must be in relapse or persistency after receiving first line chemo-radiotherapy and one or more lines of palliative chemotherapy. * karnofsky score of 80 or more. * a ct scan will be performed in all patients to assess measurable target lesions. * the clinical diagnosis must be evaluated by more than clinical investigator inclusion criteria: * patients who give their written consent of participation in this study. * patients with recurrent or persistent cervical-uterine cancer, with local and/or systemic disease with measurable lesions, whether by physical examination, ct scan or mri detected at least in the previous 6 weeks. if there is only one lesion and it is less than 10 mm in length, a biopsy confirmation is required. * patients currently receiving a second, third line or more of palliative chemotherapy diagnosed at least 30 days after the last chemotherapy. * patients with one of the following histopathological reports: squamous cell carcinoma (epidermoid carcinoma), adenocarcinoma, adenosquamous carcinoma or glassy cell carcinoma. * patients must be older than 18 years old. * ecog score no worst than 3. * patients with life expectancy greater than 4 weeks. * patients with left ventricle ejection fraction (lvef) ≥ 50 measured by radioisotopic ventriculography. * patients who meet all previous criteria with previously radiated metastatic disease in the central nervous system will be included. * patients with normal functioning of the bone marrow and other organs as defined by the following parameters: * hemoglobin ≥ 9 g/l * leucocytes ≥ 4000/microl * absolute neutrophil count ≥ 1500/microl * platelet count ≥ 100000/microl * total serum bilirubin: up to 1.5 times the normal value * total proteins: within normal limits * ast and alt =/\< 2.5 times the normal superior limit of the institutional laboratory * serum creatinine: within normal limits or up to 2 mg and gfr ≥ 60ml/min calculated with the cockcroft-gault equation. exclusion criteria: * pregnant or nursing mothers. * patients with cervical-uterine cancer with a histopathological report of: small cell carcinoma and/or neuroendocrine tumor. * patients currently receiving another investigational onco-specific drug. * patients with a history of allergy to chemical substances with similar chemical composition to that of the monoclonal antibody or chemotherapeutic agents used in this study. * patients with non-controlled co-morbid states such as active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, uncompensated diabetes and/or psychiatric illness. * presence of a second tumor. with the exception of those patients who have received adequate treatment for skin carcinomas (basal or squamous). * previous or concomitant malignancy except non-melanoma skin carcinoma. * social, familiar or geographic conditions that suggest poor attachment to the study. discontinuation of treatment criteria: * at the patient´s request. * progression of disease causing worsening of the patient´s overall status in non manageable clinical conditions, (ecog worst than 3). * death. * discontinuation of monitoring and/or loss of patient follow-up for more than 2 months. * severe adverse reaction grade 4 according to ctcae.

Keywords: uterine cervical cancer palliative treatment monoclonal antibody nimotuzumab